UNISURGE TISSUE COLLECTION SYSTEM FOR ENDOS SURG— 510(k) K914922

Substantially Equivalent

Charles L. Rose and Co., Inc.

FDA 510(k) clearance K914922 for UNISURGE TISSUE COLLECTION SYSTEM FOR ENDOS SURG, Substantially Equivalent on 1992-03-26. Applicant: Charles L. Rose and Co., Inc..

Clearance details

Applicant: Charles L. Rose and Co., Inc.
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 1991-11-04
Decision date: 1992-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

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Adverse events under product code GCJ

product code GCJ

Death: 39
Injury: 1,638
Malfunction: 28,216
Other: 11
Total: 29,904

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.